Denise C. Snyder

Effects of Home-Based Diet and Exercise on Functional Outcomes Among Older, Overweight Long-term Cancer Survivors: RENEW: A Randomized Controlled Trial

CONTEXT Five-year survival rates for early stage colorectal, breast, and prostate cancer currently exceed 90% and are increasing. Cancer survivors are at greater risk for second malignancies, other comorbidities, and accelerated functional decline. Lifestyle interventions may provide benefit, but it is unknown whether long-term cancer survivors can modify their lifestyle behaviors sufficiently to improve functional status. OBJECTIVE To determine whether a telephone counseling and mailed print material-based diet and exercise intervention is effective in reorienting functional decline in older, overweight cancer survivors. DESIGN, SETTING, AND PARTICIPANTS Randomized controlled trial of 641 overweight (body mass index > or = 25 and < 40), long-term (> or = 5 years) survivors (aged 65-91 years) of colorectal, breast, and prostate cancer, who were randomly assigned to an intervention group (n = 319) or delayed intervention (control) group (n = 322) in Canada, the United Kingdom, and 21 US states. Individuals were recruited for the Reach out to Enhance Wellness (RENEW) trial from July 1, 2005, through May 17, 2007. INTERVENTION A 12-month, home-based tailored program of telephone counseling and mailed materials promoting exercise, improved diet quality, and modest weight loss. The control group was wait-listed for 12 months. MAIN OUTCOME MEASURES Change in self-reported physical function on the Short-Form 36 physical function subscale (score range, 0-100; a high score indicates better functioning) from baseline to 12 months was the primary end point. Secondary outcomes included changes in function on the basic and advanced lower extremity function subscales of the Late Life Function and Disability Index (score range, 0-100), physical activity, body mass index, and overall health-related quality of life. RESULTS The mean baseline Short-Form 36 physical function score was 75.7. At the 12-month follow-up, the mean function scores declined less rapidly in the intervention group (-2.15; 95% confidence interval [CI], -0.36 to -3.93) compared with the control group (-4.84; 95% CI, -3.04 to -6.63) (P = .03). The mean baseline basic lower extremity function score was 78.2. The mean changes in basic lower extremity function were 0.34 (95% CI, -0.84 to 1.52) in the intervention group compared with -1.89 (95% CI, -0.70 to -3.09) in the control group (P = .005). Physical activity, dietary behaviors, and overall quality of life increased significantly in the intervention group compared with the control group, and weight loss also was greater (2.06 kg [95% CI, 1.69 to 2.43 kg] vs 0.92 kg [95% CI, 0.51 to 1.33 kg], respectively; P < .001). CONCLUSION Among older, long-term survivors of colorectal, breast, and prostate cancer, a diet and exercise intervention reduced the rate of self-reported functional decline compared with no intervention. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00303875.

Lifestyle Intervention Development Study to Improve Physical Function in Older Adults With Cancer: Outcomes From Project LEAD

PURPOSE Declines in physical functioning (PF) among elderly cancer patients threaten quality of life and the ability to maintain independence. Adherence to healthy lifestyle behaviors may prevent functional decline. PATIENTS AND METHODS Project Leading the Way in Exercise and Diet (LEAD), an intervention development study of the Pepper Older Americans Independence Center, aimed to determine whether breast and prostate cancer survivors (age 65+ years) assigned to a 6-month home-based diet and exercise intervention experienced improvements in PF when compared with an attention control arm receiving general health information. An accrual target was set at 420, and PF (Short Form-36 subscale), physical activity (Community Healthy Activities Models Program for Seniors), and diet quality (index from 3-day recalls) were assessed at baseline and at 6 and 12 months (6 months after intervention). RESULTS This developmental project did not achieve its accrual target (N = 182); however, PF change scores were in the direction and of the magnitude projected. Baseline to 6-month change scores in the intervention versus the control arms were as follows: PF, +3.1 v -0.5 (P = .23); physical activity energy expenditure, +111 kcal/wk v -400 kcal/wk (P = .13); and diet quality index, +2.2 v -2.9 (P = .003), respectively. Differences between arms diminished during the postintervention period. CONCLUSION These findings suggest that home-based diet and exercise interventions hold promise in improving lifestyle behaviors among older cancer survivors, changes that trend toward improved PF. Future studies should incorporate larger sample sizes and interventions that sustain long-term effects and also take into account secular trends; these efforts will require adequate planning and resources to overcome the numerous barriers to intervening in this difficult to reach yet vulnerable population.

Flaxseed Supplementation (Not Dietary Fat Restriction) Reduces Prostate Cancer Proliferation Rates in Men Presurgery

Background: Prostate cancer affects one of six men during their lifetime. Dietary factors are postulated to influence the development and progression of prostate cancer. Low-fat diets and flaxseed supplementation may offer potentially protective strategies. Methods: We undertook a multisite, randomized controlled trial to test the effects of low-fat and/or flaxseed-supplemented diets on the biology of the prostate and other biomarkers. Prostate cancer patients (n = 161) scheduled at least 21 days before prostatectomy were randomly assigned to one of the following arms: (a) control (usual diet), (b) flaxseed-supplemented diet (30 g/d), (c) low-fat diet (<20% total energy), or (d) flaxseed-supplemented, low-fat diet. Blood was drawn at baseline and before surgery and analyzed for prostate-specific antigen, sex hormone-binding globulin, testosterone, insulin-like growth factor-I and binding protein-3, C-reactive protein, and total and low-density lipoprotein cholesterol. Tumors were assessed for proliferation (Ki-67, the primary endpoint) and apoptosis. Results: Men were on protocol an average of 30 days. Proliferation rates were significantly lower (P < 0.002) among men assigned to the flaxseed arms. Median Ki-67-positive cells/total nuclei ratios (×100) were 1.66 (flaxseed-supplemented diet) and 1.50 (flaxseed-supplemented, low-fat diet) versus 3.23 (control) and 2.56 (low-fat diet). No differences were observed between arms with regard to side effects, apoptosis, and most serologic endpoints; however, men on low-fat diets experienced significant decreases in serum cholesterol (P = 0.048). Conclusions: Findings suggest that flaxseed is safe and associated with biological alterations that may be protective for prostate cancer. Data also further support low-fat diets to manage serum cholesterol. (Cancer Epidemiol Biomarkers Prev 2008;17(12):3577–87)

Results of a diet/exercise feasibility trial to prevent adverse body composition change in breast cancer patients on adjuvant chemotherapy.

PURPOSE Patients with breast cancer on adjuvant chemotherapy can experience weight gain and concurrent losses in muscle mass. Exercise interventions can prevent these changes, but time and travel pose barriers to participation. The Survivor Training for Enhancing Total Health (STRENGTH) trial assessed the feasibility and impact of 2 home-based interventions. PATIENTS AND METHODS Ninety premenopausal patients with breast cancer on adjuvant chemotherapy were randomized to a calcium-rich diet (CA) intervention (attention control) or to 2 experimental arms: a CA + exercise (EX) arm or a CA + EX and high fruit and vegetable, low-fat diet (FVLF) arm. Exercise arms included aerobic and strength-training exercises. Body composition, weight status, waist circumference, dietary intake, physical activity, quality of life, anxiety, depression, serum lipids, sex hormone binding globulin, insulin, proinsulin, C-reactive protein, interleukin-1B, and tumor-necrosis factor receptor-II were measured at baseline and at 6-month follow-up. RESULTS Accrual targets were achieved and modest attrition was observed (8.8%). Self-reports suggest increased calcium intakes in all arms, and higher fruit and vegetable and lower fat intake in the CA + EX + FVLF arm; no differences in physical activity were observed. While measures of adiposity were generally lower in the CA + EX + FVLF arm, the only significant difference was in percentage of body fat (arms and legs); change in scores (mean +/- standard deviation) were +0.7% +/- 2.3% (CA); +1.2% +/- 2.7% (CA + EX); and +0.1% +/- 2% (CA + EX + FVLF; P = .047). Lean body mass was largely preserved, even in the control arm (net gain of 452 g +/- 2395 g). No differences were observed in other endpoints. CONCLUSION Diet and exercise interventions can prevent weight gain and adverse body composition changes, but more research is needed to determine optimally effective interventions that can be implemented during active treatment and that promote adherence.

Reach Out to Enhance Wellness Home-Based Diet-Exercise Intervention Promotes Reproducible and Sustainable Long-Term Improvements in Health Behaviors, Body Weight, and Physical Functioning in Older, Overweight/Obese Cancer Survivors

PURPOSE Diet and exercise interventions have been tested in cancer survivors as a means to reduce late effects and comorbidity, but few have assessed adherence and health outcomes long term. METHODS Between July 2005 and May 2007, the Reach Out to Enhance Wellness (RENEW) trial accrued 641 locoregionally staged, long-term (≥ 5 years from diagnosis) colorectal, breast, and prostate cancer survivors in the United States (21 states), Canada, and the United Kingdom. All participants were sedentary (< 150 minutes of physical activity [PA] a week), overweight or obese (body mass index, 25 to 40 kg/m(2)), and over age 65 years. The trial tested a diet-exercise intervention delivered via mailed print materials and telephone counseling. RENEW used a wait-list control, cross-over design (ie, participants received the year-long intervention immediately or after a 1-year delay), which allowed the opportunity to assess program efficacy (previously reported primary outcome), durability, and reproducibility (reported herein). Measures included diet quality (DQ), PA, BMI, and physical function (PF). RESULTS No significant relapse was observed in the immediate-intervention arm for DQ, PA, and BMI; however, rates of functional decline increased when the intervention ceased. From year 1 to year 2, significant improvements were observed in the delayed-intervention arm; mean change scores in behaviors and BMI and PF slopes were as follows: DQ score, 5.2 (95% CI, 3.4 to 7.0); PA, 45.8 min/wk (95% CI, 26.9 to 64.6 min/wk); BMI, -0.56 (95% CI, -0.75 to -0.36); and Short Form-36 PF, -1.02 versus -5.52 (P < .001 for all measures). Overall, both arms experienced significant improvements in DQ, PA, and BMI from baseline to 2-year follow-up (P < .001). CONCLUSION Older cancer survivors respond favorably to lifestyle interventions and make durable changes in DQ and PA that contribute to sustained weight loss. These changes positively reorient functional decline trajectories during intervention delivery.

Phytochemicals and Cancer Risk A Review of the Epidemiological Evidence

A number of epidemiological studies have investigated associations between various phytochemicals and cancer risk. Phytoestrogens and carotenoids are the two most commonly studied classes of phytochemicals; phytosterols, isothiocyanates, and chlorophyll also have been investigated, although to a much lesser extent. Because there have been no systematic reviews of the literature on all phytochemicals and cancer risk to date, this article systematically reviews 96 published epidemiological studies that examined associations between phytochemicals and cancer risk. Most studies found null associations between individual phytochemicals and cancer risk at various sites. In addition, results from past studies have been largely inconsistent, and observed associations have been of relatively modest magnitude. The most consistent protective effects were observed for higher levels--dietary intake, serum, plasma, or urinary metabolites--of β-carotene and renal cell cancer, β-cryptoxanthin and lung cancer, isothiocyanates and lung cancer, isothiocyanates and gastrointestinal cancer, lignans and postmenopausal breast cancer, and flavonoids and lung cancer. Although elevated risk of certain cancers with higher levels of certain phytochemicals was observed, an insufficient pool of studies examining the same associations or inconsistent findings across studies limit the ability to conclude that any one phytochemical increases cancer risk. Additional research is needed to support previously identified associations in cases where only one study has examined a particular relationship. Importantly, continued research efforts are needed to evaluate the cumulative and interactive effects of numerous phytochemicals and phytochemical-rich foods on cancer risk.

Design of FRESH START: A Randomized Trial of Exercise and Diet among Cancer Survivors.

PURPOSE FRESH START is a randomized controlled trial that will test whether a personally tailored, distance-medicine-based program will increase exercise and fruit and vegetable consumption, and decrease fat intake of individuals recently diagnosed with breast or prostate cancer. METHODS Early-stage breast and prostate cancer cases (N= 530) will be identified within 9 months of diagnosis from hospital cancer registries and large oncologic practices throughout the United States. These individuals will be sent a letter of invitation and screened for eligibility. After a baseline telephone interview, participants will be randomized into one of two arms that receive materials aimed at increasing exercise and fruit and vegetable intake, and decreasing dietary fat: 1). an experimental arm that receives a workbook and a series of six 4-page newsletters delivered every 7 wk and personally tailored on type of cancer, cancer coping style, race, age, self-efficacy, stage of readiness, and barriers and/or progress toward goal behavior (i.e., >or= 30 min of exercise at least 5 d.wk, >or= 5 servings of vegetables and fruit per day, and <or= 30% of calories from fat); or 2). a control arm that receives a series of nontailored health brochures. Follow-up interviews scheduled 1 and 2 yr postbaseline will determine short- and long-term efficacy and the effects of the interventions on other endpoints (quality of life, perceived health, etc.). Factors, such as gender, race, and social support, also will be explored to determine potential interactions with program efficacy. CONCLUSION Given the growing number of cancer survivors, distance-medicine-based interventions addressing multiple behaviors and targeting this high-risk group have the potential to make a positive and broad public health impact.

Comparing the 7-day Physical Activity Recall with a Triaxial Accelerometer for Measuring Time in Exercise

PURPOSE The primary study aim was to evaluate associations of estimated weekly minutes of moderate-to-vigorous-intensity exercise from self-reports of the telephone-administered 7-Day Physical Activity Recall (7-Day PAR) with data captured by the RT3 triaxial accelerometer. METHODS This investigation was undertaken as part of the FRESH START study, a randomized clinical trial that tested an iteratively tailored diet and exercise mailed print intervention among newly diagnosed breast and prostate cancer survivors. A convenience sample of 139 medically eligible subjects living within a 60-mile radius of the study center provided both 7-Day PAR and accelerometer data at enrollment. Ultimately, substudy subjects (n = 115) were found eligible for the FRESH START study and randomized to one of two study treatment arms. Follow-up assessments at year 1 (n = 103) and year 2 (n = 99) provided both the 7-Day PAR and the accelerometer data. RESULTS There was moderate agreement between the 7-Day PAR and the accelerometer with longitudinal serial correlation coefficients of 0.54 (baseline), 0.24 (year 1), and 0.53 (year 2), all P values <0.01, although the accelerometer estimates for weekly time in moderate-to-vigorous physical activity (PA) were much higher than those of the 7-Day PAR at all time points. The two methods were poorly correlated in assessing sensitivity to change from baseline to year 1 (rho = 0.11, P = 0.30). Using mixed models repeated-measures analysis, both methods exhibited similar nonsignificant treatment arm x time interaction P values (7-Day PAR = 0.22, accelerometer = 0.23). CONCLUSIONS The correlations for three serial time points were in agreement with findings of other studies that compared self-reported time in exercise with PA captured by accelerometry. However, these methods capture somewhat different dimensions of PA and provide differing estimates of change over time.

Physical function and associations with diet and exercise: Results of a cross-sectional survey among elders with breast or prostate cancer.

BackgroundFunctional decline threatens independent living and is common among individuals diagnosed with cancer, especially those who are elderly. The purpose of this study was to explore whether dietary and exercise practices are associated with physical function status among older cancer survivors.MethodsMailed surveys were used to ascertain data on physical function, dietary fat, fruit and vegetable (F&V) consumption, and exercise among elderly diagnosed with early stage (I-II) breast (N = 286) or prostate cancer (N = 402) within the past 18 months.ResultsSixty-one percent of respondents reported diets with <30% of energy from fat, 20.4% reported F&V intakes of 5+ daily servings, and 44.6% reported regular vigorous exercise. Significant, independent associations were found between physical functioning and reported dietary fat intake, F&V consumption, and exercise. A simultaneous multiple regression model controlled for age, race, gender, time since diagnosis and concurrent health behaviors yielded the following estimates: (1) 0.2 increase in the SF-36 physical function subscale (PFS) score with each reported 1% decrease in percent energy from fat (p < .0001); (2) 0.9 increase in the SF-36 PFS score for each reported serving of F&V/day (p = .0049); and (3) 15.4 increase in the SF-36 PFS score with a positive response for regular vigorous exercise (p < .0001).ConclusionsResults of this cross-sectional survey suggest that regular vigorous exercise and consumption of diets low in fat and rich in F&Vs are associated with higher levels of physical functioning among older cancer survivors. Interventions that promote healthful lifestyle change may deliver considerable benefit within this ever increasing and vulnerable population.

Reach Out to Enhance Wellness in Older Cancer Survivors (RENEW): Design, Methods and Recruitment Challenges of a Home-based Exercise and Diet Intervention to Improve Physical Function among Long-term Survivors of Breast, Prostate, and Colorectal Cancer

Objective: Cure rates for cancer are increasing, especially for breast, prostate, and colorectal cancer. Despite positive trends in survivorship, a cancer diagnosis can trigger accelerated functional decline that can threaten independence, reduce quality‐of‐life and increase healthcare costs, especially among the elderly who comprise the majority of survivors. Lifestyle interventions may hold promise in reorienting functional decline in older cancer survivors, but few studies have been conducted.